Jessica (00:00.525)
Took me a long time.
Kim (00:03.075)
Yeah, okay. Hello everybody. Welcome to Dr. Jessica McKinney. Nice to see you. Thank you so much for joining me today.
Jessica (00:13.525)
Thank you, Kim. Really happy to be here, thanks.
Kim (00:16.05)
Yeah, we have kind of, we've been in this pelvic health space for many, many years and we actually got to meet in person several years ago at a very fun event. But you've been up to some really cool things since then and sort of made a little bit of a shift in terms of still in pelvic health, but the way that you were, I guess, focusing your efforts. So can you start out by talking a little bit about what brought you into first into the pelvic health space and then now to
what you're doing now.
Jessica (00:46.709)
Yeah, sure. Thanks so much for asking. It definitely has been a big shift, and I appreciate the chance to tell that story. But I was drawn to public health when I was finishing PT school. And it was really something that I recognize now and didn't have the words to name then. But it was a desire to really build capacity. It's like I saw this need in my very last clinical affiliation.
where I didn't expect to get any pelvic health exposure. Was very surprised by that in the clinic where I landed, but it was truly life-changing. Getting to hear the stories of the women that were coming in and talking to the clinicians under whom I was working, and just getting a sense of kind of the impact that the various pelvic health conditions had on their lives and how meaningful it was for them.
to have people that heard their stories, that validated their experiences and helped them on a path to recovery, just resonated. And I was like, I felt like I've seen this need and I didn't know I wanted to be a part of it, but I can't unsee it. I can't go back and pretend that I didn't see this, that I don't have this awareness now. So it was a real shift for me. So I came out, I mean,
Kim (01:58.185)
Mm.
Jessica (02:06.553)
green as anybody could be coming out of school and just knowing I've got a lot to learn, but I knew I wanted to be in that space and I wanted to contribute meaningfully in the space of women's and pelvic health. And so as I look back on my career, I recognized then it was this desire to build capacity. Like I didn't have those words, but I could see that there was something that we could do.
therapeutically, something we could do that was meaningful, that there wasn't enough of. And I wanted to be a part of trying to build more of that. So that took me into a private PT practice in the Chicago area for a couple years right out of school. I moved to the Boston area and started to practice with my husband, who's also a PT, and really continued to build capacity in both of those settings.
Kim (02:39.415)
Mm-hmm.
Jessica (03:01.741)
the practice in the Boston area, we grew to several locations, worked with an incredible number of PTs and OTs and fitness professionals over a number of years, really trying to build up community-based capacity for women's and pelvic health. And after some 15 years or so of doing that, was feeling like, hey, I did all the things I thought I was supposed to do, like, you know.
training students and training other professionals and hiring and building a team and felt like no matter what we do, there's still a waiting list. And I know for every person getting in to see us, there are so many other people not getting care. So I was troubled by that, and really trying to figure out what would be the next thing. And that's when I encountered.
the product that I'd been working on and kind of had been thinking about, well, what about digital health? What about group-based care? Like kind of where is there a way to innovate in care models with technology and so forth to try to deliver something therapeutic to greater numbers of people? And so that kind of started my pivot into industry, which was just kind of following that one footstep after another on that population health, building capacity in women's and pelvic health care.
Kim (04:26.806)
That's awesome. And how did you find the group that you now work with, the company that, were they already established or were you seeking out people and saying, hey, I've got this idea, let's start a business? How did that happen?
Jessica (04:39.461)
No, they found me. They were, it was a founding CEO and the clinical inventor of the product, starting a company that was in Boston and really had this desire to kind of commercialize around the product, Leva, that we're working on and build capacity through delivering a way to scale pelvic floor muscle training. So they were...
They got my name and reached out a couple times. And I was reluctant to take the meeting at first, I'll be honest. I mean, I was busy doing what I was doing. I had a lot of focus, a lot of things I was working on. And, but I'm glad I did. I mean, I took it and was really compelled by what I saw, kind of in the nuts and bolts of what this product was.
but also the potential that I could see it had with further development and the real need it could fit in the space. So I worked as an advisor for the company for about a year and then joined full-time at the end of 2017.
Kim (05:38.606)
Mm-hmm.
Kim (05:47.422)
Amazing. So what's the name of the company? You've talked about the product. What's the name of the company and during that year as an advisor, what was what were you tasked with and how like was there any sort of prototype with the Leavis system yet?
Jessica (06:01.961)
Yeah, so at that point, there was a FDA cleared product. So it was a first generation product and we can talk more later, but we have a second generation product now. It was with a different company. So there was a prior company at that point. And my role as the advisor was really contributing a lot of subject matter expertise around the pelvic floor functional anatomy.
therapeutic interventions and so forth. And I would say kind of in a nutshell, a lot of it led to contributions in the area of clinical development, product development, and education, broadly speaking. So education of, you know, kind of staff and people within the company, health education directed outward toward the general population or to healthcare professionals.
Kim (06:55.618)
So let's talk about the, I want to go first, before we lay the foundation, many listeners already have a general understanding of the pelvic floor, but I want to go first to the product and then we'll start kind of addressing how it can help with certain conditions. Does that make sense? Yeah, so what is the, what is the LEVA system?
Jessica (07:12.069)
Yes.
Jessica (07:15.561)
So the LEVA system is a FDA cleared pelvic floor muscle training system for the treatment of stress mixed and mild to moderate urgency incontinence, fecal incontinence that's been present for three months or more. And for general pelvic floor muscle weakness. So strengthening to support that. It's a combination of hardware and software. So there is a device component, a hardware component, that's an intravaginal wand that has six motion sensors. So it's a flexible,
that is inserted intervaginally during pelvic floor muscle exercises. And then a woman, sorry, can we pause for just a moment? Are we able to edit? Yeah, there is a window open and all of a sudden, like I am sweating. So I was like, I don't think I can keep going on because the normal adrenaline of talking and I was like, something's going on and I'm distracted by that, thank you.
Kim (07:55.698)
Of course. Yeah.
Kim (08:02.19)
Okay.
Kim (08:09.086)
Yeah, it's all good.
Jessica (08:15.937)
Yeah, oh my goodness. Yeah, I knew from doing that, I was like, I know there'll be some editing that's done and I just needed to pause that. Whew, I'm sorry, it was like, just started.
Kim (08:18.367)
I know the feeling.
Kim (08:24.191)
Yeah, all good.
Kim (08:32.238)
That happens to me too, that I can feel like the sweat dripping down my arms and my side. And you just like, you're like, don't move, don't move, don't move. Okay. Just sit and then you're like, is it dripping off my face? Is it?
Jessica (08:36.684)
Holy!
Jessica (08:43.081)
Honestly, that's it. And I'm like, I'm not typically a sweater, but you know, like maybe this is, you know, perimenopause hitting. I don't really know. I'm, yeah. I am, I'm close, but so anyway, I was just like, my physiology is not cooperating at the moment. And it's like, we've got to regroup here.
Kim (08:53.047)
Oh I'm full post menopause now so yeah it's uh... Fun and games.
Kim (09:07.896)
Yeah, all good.
Jessica (09:08.757)
While we're on this brief pause, one thing I didn't do is like, there was a company called Renovia itch down for lack of funding. I mean, I think you're familiar with that background and I thought it was probably better to not name that company. So like as we pick back up, I can name like a Xena, Xena was formed, Marshallize's product, blah, blah. Because I have like a couple of talking points off the prompts that you gave me. So I've got that. So thanks.
Kim (09:14.583)
Yes.
Kim (09:20.842)
Sure. Yep.
Kim (09:26.87)
Yep.
Yep.
Kim (09:35.114)
Yeah. Yeah, yeah, yeah. Totally fine. Totally fine. All good. Okay.
Jessica (09:38.321)
Okay. I think I'm calmed down now. Yeah, my notes are closed and I think I'm doing better. Jeez.
Kim (09:47.352)
I know, I know, I know the feeling. Okay, so I would have just asked you about what is the Levis system and, yeah, so what's the Levis system and how does it help? So yeah, so you can just pick back up there.
Jessica (09:54.253)
He thinks he's a distracted product, right?
Jessica (10:02.946)
Sure.
So, LEVA is an FDA cleared product. The clearances are for treating stress mixed in mild to moderate urgency incontinence, fecal incontinence that's been present for three months or more, and treating pelvic floor muscle weakness. It is designed around the principles of pelvic floor muscle training. It's an intravaginal wand that has motion sensors. So, you know, it's kind of distinct in that mechanism. There are six motion sensors on a flexible intravaginal wand.
so that's inserted when somebody does their pelvic floor muscle exercises, and it syncs to software on a woman's smartphone that provides real-time feedback that is motion-based on how someone's doing their exercises, so they see movement in a correct direction if they are engaging the pelvic floor muscles correctly or don't see movement or see it in the incorrect
Jessica (11:03.611)
training protocol that is what we've tested in clinical studies, as well as kind of a robust library of health education that's really been designed based on the evidence around behavior change, around the facilitators of adherence to pelvic floor muscle training programs, such as the ability to set reminders that are at personalized times, a lot of the kind of basic understanding of like, what is the pelvic floor and where is it and why.
Why is it that these exercises should help with myocontinence and helping to understand like kind of normal bowel and bladder function and what those goals are?
Kim (11:43.062)
That's amazing. So I guess let's talk about what makes a good pelvic floor muscle training session. So what are the reasons why somebody may have fecal incontinence or urinary incontinence or urgency overactive bladder? And then what are the mechanisms by which pelvic floor exercise is helping?
Jessica (12:08.421)
Sure. So I'll kind of frame it up from the perspective of like defining pelvic floor muscle training maybe first. So that is a term that is used and really defined in the literature as a program that is a series of exercises that address strength.
coordination, endurance, and power, maybe one or all of those different parameters of muscle performance. And it is the cornerstone really of a first line care for urinary and fecal incontinence. That is well established globally through multiple.
randomized controlled trials through professional society guidelines and leading health organizations really kind of endorsing this idea that this training these muscles through programs of pelvic floor muscle training constitute a key component of first line care. And the reason for that is that
for a number of reasons, the pelvic floor muscles may be weak, but they may lack coordination, they may lack endurance. And so, you know, programs that address kind of restoring function through those different components of muscle performance have been shown to be beneficial, you know, for resolving either fully or improving meaningfully symptoms of incontinence.
And so, you know, that is kind of we're building off of, you know, decades and, you know, really centuries of recognizing the importance of these muscles in kind of pelvic health generally, in rehabilitation when there are problems and kind of restoring the normal function of the pelvic floor.
Kim (13:44.768)
Mm-hmm.
Kim (14:00.81)
Right. So with the wand, you mentioned there's motion sensors and there are some other, you know, technology has come into the pelvic health space and a criticism has often been that it's, it can detect motion that may not be the correct motion. So you've talked about how this can determine if it's correct and if it's not correct. So how, how does it do that? How is this different from some of the other biofeedback devices that are out there?
Jessica (14:29.341)
Yes, so the number of motion sensors that are used is one of the ways that that's different. So motion is the primary driver of the information that's gathered when someone is using LEVA. And this is based on everything that we know really about the functional anatomy of the pelvic floor. So when the pelvic floor muscles contract.
optimally, there is a lifting and a squeezing component. And that the levator anae, the deepest muscles that really are the workhorse of the collective pelvic floor when we're doing training, that lifting is kind of, if you're standing upright, is really like toward the head. But there's also this squeezing component there that is more of a compression.
So kind of a horizontal movement that is going from the back toward the front. So kind of toward the inside of the pubic bone. So together, when you combine both a lift and a squeeze like that, you get angular motion.
So angular motion is truly what we're capturing by using six different sensors that are at fixed distances from each other on a flexible circuit. So when the leva is inserted, it conforms to the shape of a woman's vagina. So it doesn't go into take up space, but it just kind of.
conforms and then there's an image or a line, a line image on the screen. And when she does her exercises, it will pick up that angular motion that we have that is, we know what good looks like because of what we know about functional anatomy. And there are other components that have been built in to leave us such that if someone is just getting started, it will zero to her starting point.
Kim (16:05.739)
Right.
Jessica (16:18.045)
So, you know, there is guidance around the orientation of LEVA when it's in place in the vagina, such that, you know, if you put it in the right way and then it spins a little bit, like it will know that it's out of position and it won't continue to just provide some information. It will stop the exercise session and say, you've got to fix the orientation of LEVA. And then it also zeros to someone's baseline.
Jessica (16:48.013)
that there can be an over-emphasis on, you know, lift, squeeze, hold, and then not relaxing. Yeah, so the ability to relax is one of the components. Like, that's the coordination. We need to be strong. We need to be able to turn muscles on. We need to be able to turn them off. And so, this has really been built to coach both the lifting, holding, you know, squeezing component, and...
Kim (16:53.518)
Hehehe
Jessica (17:16.053)
Now you go into an active rest where you're actively trying to let go of the muscles and get back to the baseline where you started. Kind of like you're working a range of motion, you know, or the excursion of the pelvic floor during that time.
Kim (17:25.944)
Mm-hmm.
Kim (17:30.25)
Yeah, that's so interesting. I think about the so if somebody had a prolapse or multiple compartment even with prolapse and there's a there's bulges that make it in the way. Could there could discomfort from that or could that could that limit the effectiveness of? Well, first of all, could it limit the effectiveness of somebody's pelvic floor exercise just in general? But then with the lever, is there any reason why that would be, you know?
Jessica (17:54.105)
Mm-hmm.
Kim (18:00.243)
something that's hindering people if they had bulges that were in the way.
Jessica (18:05.349)
Yes, I mean, in short, that's true. We know that a lot of times in certainly more advanced pelvic organ prolapse, there is underlying damage to the musculature. And it may be such that the muscles cannot function in whole. That is really impaired. And so while pelvic floor muscle training may be important to do to the best of one's
Jessica (18:34.523)
much more individualization of the therapeutic program. We certainly have had a lot of women who, prolapse is off label, but have reported that is something that they have in addition to the incontinence that they have. So we are not indicated for pelvic organ prolapse, to be very clear, that's not an indication for LEVA. And...
Kim (18:37.612)
Right.
Jessica (19:03.729)
So there could be a situation where if someone's prolapse is not supported, that they can't insert and retain LEVA to do the exercises because essentially the prolapse is moving to the opening and it doesn't stay in. So there are times people have used it with a pessary, but I think that kind of the more symptomatic and the more
Kim (19:18.486)
Right, right.
Kim (19:26.914)
Mm-hmm.
Jessica (19:32.609)
management is required for one's prolapse, the more, you know, the more management would be required to figure out if LEVA is appropriate in the first place.
Kim (19:41.782)
Right, yeah, fair enough. And so for people that are using the LEVA system, what's the training protocol in terms of time, repetition, sets, are there different programs for urgency versus stress, urinary incontinence, or how does that work?
Jessica (20:00.869)
Yeah, so the physical exercise component is the same. It's a pre-programmed session that is five repetitions, each 15 seconds of working and 15 seconds of the active rest. So one training session would amount to about two and a half minutes and it's performed in standing. So these are some of the things that are, you know.
slightly off the beaten path of I think what we see a lot in the literature. But it's the training program that was developed by the clinical founder, who is an OBGYN, who just really set about to identify a way to create a device that could provide feedback on the lifting component very specifically. And it's like, you know, other things will reflect information on squeeze, lifting is crucial, like to be able to capture that.
And after all of his research and experimentation, ended up with the types of motion sensors we use and the kind of the way that they're used in this flexible array, a linear array, and the training program. It's pretty challenging for people to do. And so most people don't start with being able to complete 15 seconds of a sustained contraction.
But the way that the program we see kind of practically progresses is that someone starts and they're just doing the best they can during the work cycle and kind of it might even amount to almost some flickers, like kind of are on and holding for a few seconds and then relaxing. And then they rest fully for the 15 seconds off. And then gradually are able to hold, kind of moving through a greater.
degrees of change, it's measured in degrees, and holding for greater duration within that 15 seconds. So that's what's pre-programmed, and that kind of program of one exercise session being comprised of the five repetitions is two times a day, as recommended in the commercial program. And we've tested that exercise dosing, essentially, in the clinical trials we've done as well.
Kim (22:16.486)
That's so interesting that it's in standing because that's often I feel like, you know, maybe a limitation to some I think it's a good starting base point for some people but at the end of the day training on our backs is not Representative of what's happening when we're standing up. So I love that you're addressing that So when you so now when it's inserted are we
Jessica (22:20.846)
Thank you.
Jessica (22:34.137)
I'm sorry.
Kim (22:38.15)
when it's inserted do we hold on to it or is it is are we supposed to have the capacity for it to be inserted without us like physically holding it with say a hand?
Jessica (22:46.593)
Right, so there are a couple ways that it ends up staying in place during the short duration of the exercises. One solution a lot of people use is just kind of pulling up their underwear. And that provides just a little bit of a backdrop to stabilize the base of the LEVA, which is kind of a squared off base. Got one here. So like this is...
Kim (22:58.483)
Right, yep.
Kim (23:02.2)
Yeah.
Kim (23:10.826)
Yeah, for those of you who are listening, if you head over to the YouTube channel, you'll be able to see the video where she's demonstrating it. Okay, sorry, carry on.
Jessica (23:18.061)
Yeah, so no, of course. So it's like less than about an inch square as a flat base, but that part can be resting just against the underwear and can help to hold it in place as leave is inserted and kind of is in the vagina like this. So that's a solution a lot of people use. There are some people for whom they just can stand still and it's held in place just with tissue approximation. And some people are using a hand to provide some external support.
Kim (23:33.654)
Mm-hmm.
Kim (23:43.819)
Mm-hmm.
Kim (23:47.97)
Mm-hmm.
Jessica (23:49.209)
We have a care management team, so people that are coaches that work one-on-one with anyone who's using LEVA, that that's included in the program. And so if people are having some trouble figuring out how to get it to stay in place during the time they do the exercises, that team is fantastic at working with them and troubleshooting different ways to make it work.
Kim (24:11.978)
Yeah, that's an amazing additional support. I know sometimes we purchase these products and we might have a little bit of a brochure, but we're just sort of fumbling through, am I doing it right, am I not? So that's an amazing service. So right now, as I understand it, this is available through a physician with prescription only, is that correct?
Jessica (24:31.553)
So it is prescription only. There are other clinicians that have prescribing capabilities such as a PA or an NP, who also could, but it is by prescription only. And I mean, that is, as you look at it, probably, it's a very strategic thing. I mean, we really believe that incontinence is a health condition, not a nuisance and something to kind of be.
Kim (24:58.615)
Right.
Jessica (25:00.873)
you know, tsk tsk, manage however you want and figure it out. You know, but really believe that having clinicians involved as a touch point even is a really important piece of getting something, you know, therapeutic and also having people that are there for them if additional care is needed, you know, if this is not enough. Mm-hmm.
Kim (25:02.988)
Right, right.
Kim (25:22.71)
Right. Right, okay. And it right now is just US, are there plans to expand any to other countries?
Jessica (25:34.465)
So I'll answer that in two ways. So we have this version of LEVA, which is a second generation from the first one that I mentioned and cleared by FDA. That is only available in the US, and that's where the focus is. So there's no current plan to explore expansion to other countries for that LEVA. But LEVA was acquired in February of this year.
by a new company, Azina Health. So that's who is currently the manufacturer of Leva. And Azina was funded by a group called AXA. So they're an impact investment fund. And with that came kind of a mandate for us to also explore how everything that we know about Leva can be extended to low and middle income settings. So.
to answer your question, we are working on a plan right now that is early stages, but that is looking at how we take all that we know and this technology and expand to come up with something that is scalable and accessible and right priced for different markets. So with that, we've...
Kim (26:45.838)
Mm-hmm.
Kim (26:52.566)
So stay tuned.
Jessica (26:53.885)
Yeah, stay tuned. So we are beginning some formative research in Kenya and Nigeria, and that's largely due to, I mean, there's great opportunity, there's great need there, and I and a colleague who's also leading this work at Azena have a long mutual history of doing global health work together that's largely been in sub-Saharan Africa, so it also was a chance to kind of bring together a lot of the relationships that we have and to build on that.
Kim (27:21.334)
That's amazing. I want to come back to fecal incontinence. So this is something that doesn't get as much air time as urinary incontinence. It is not as common, but it I would say is much more life altering than urinary incontinence. So with the LEVA, is it still inserted vaginally? And
Jessica (27:32.084)
Mm-hmm.
Kim (27:47.106)
as you said that the exercises you perform the same exact routine and that can also help with fecal incontinence, is that correct?
Jessica (27:53.441)
That's correct. That's correct. That's one of the things that is really distinct. So the use of feedback or biofeedback to guide pelvic floor muscle exercises for fecal incontinence is well established and is really a key component of addressing it. There are a lot of other things that are very important in managing fecal incontinence as well. And I don't discount those. But, but one thing that is unique is we've, we've done a pilot trial and established that there is, you know,
incontinence symptoms with people using LEVA intravaginally and we also will be pursuing some additional studies in that space.
Kim (28:36.194)
What's the reason why it's two and a half minutes twice a day compared to once a day for five minutes?
Jessica (28:45.609)
So I think the simplest answer is that it's challenging.
I mean, that two and a half minutes seems like maybe not a lot, I think, especially to people who think about prescribing greater numbers of repetitions and more involved programs, but it's really challenging. So there are some people who, from an adherence perspective, are like, I have a tough time getting in twice a day, so I'm just going to do them back to back. And anecdotally, we hear that they consistently are like, it's always really hard to do it.
Kim (28:59.214)
Mm-hmm.
Kim (29:13.485)
Mm-hmm.
Kim (29:18.826)
Right.
Jessica (29:20.475)
It's just kind of a dosing of the exercises, separating them apart so that there's a little bit of recovery time in between and each one you're able to have a little more oomph.
Kim (29:31.198)
Right, right. What's the weight of the device? If I think about, you know, if you compare, when you think of Kegel weights and tampons and that type of thing, where does it fall?
Jessica (29:41.321)
I mean, far more tampon than weight. It's, you know what I mean? It's very light. That's a number that I don't have in my head, actually is the exact weight of it, but it's incredibly light. Yeah, it doesn't really bear a lot of weight. So it's not that there's work involved in retaining it, like there would be for a weight.
Kim (29:44.51)
Yeah.
Kim (30:01.77)
Right, right, right. And the app component, I think is really cool. So that's something that's giving patient their immediate feedback, biofeedback, but it's also tracking their progress. And if I understand correctly, it also, because it's prescribed through the physician, the physician can access that data to see compliance and improvement as well. Is that the intention?
Jessica (30:26.449)
Right, right. Yeah, it's, it's kind of a lot of great features that have been built in. So you're right. Like there's one component that is the provision of the feedback. And, you know, we can, you know, we've talked about that already. And we think that that's an incredibly novel way to provide feedback and seems to be a very meaningful way to provide the feedback. But beyond that,
it captures information on adherence. So somebody has to do all five of their repetitions for it to count as an exercise session, but they don't have to keep a separate log. Like the app just recognizes that was a completed training session. And kind of one of the other features is they get little satisfying green check marks, that show up in a home screen to let them know they've completed their exercises that day. But over time that allows for a tracking of their adherence
shared with the clinician. So that's something that the coach team sees. So the coach team that supports them also sees that and can have some conversations with them, even to try to understand like, oh, I got sick or I was traveling and I forgot my LEVA. There are things like that come up. But to try to help them kind of troubleshoot or recommit because we all know that can be hard to establish a new.
behavior of any sort, especially in your health behaviors. But that information on adherence and on use is part of a monthly cadence of reporting that goes back to the prescribing clinician. Another bit of information that is included on there that's extracted from the app is their answer to the urogenital distress inventory. So that's a six question.
can bladder symptom focused, validated survey, widely used in clinical research. But we use that within the app at baseline and then at monthly intervals thereafter to be able to track symptom change over time.
Jessica (32:23.869)
That then is reported on the report. Additionally, if they're using it for bowel symptoms or fecal incontinence, we use kind of the corresponding survey called the CREDI-8, the colorectal anal distress survey. And that is included as well.
Kim (32:47.97)
That's amazing.
Jessica (32:48.41)
So, this is some of the features of the app that allow us to monitor adherence, to monitor symptom change over time. And then also there is...
kind of a cadence that's scheduled out over about three months of use of presenting them with health education in the form of videos, little short narratives and little tips and tricks that are related to bowel or bladder health or pelvic health in general. To really round that out.
Kim (33:19.31)
Perfect. And I don't think, I didn't ask and I don't think that you've said, what's, when you did your clinical trial or your research, what was the, how long, how many weeks or months was that period of time?
Jessica (33:35.009)
Yeah, so there was a very early trial that tested LEVA for six weeks, but the main trials that you'll hear us talking about is a randomized control trial that enrolled or had about 300 women who were able to evaluate their results who were randomized to either use LEVA or pelvic floor muscle training at home with written and audio visual instructions. And that was an eight week intervention. So that was kind of moving on
that and then we continued to do follow-ups. So we have published on the initial eight-week intervention. We then published on both six and 12-month data and then we presented
just last month actually at the IUGA meeting on durability of results out to two years. So we'll publish that as well. So that's, it's all been eight weeks for that. We also have published real world evidence that looked at eight week outcomes to be able to compare those as well. So that was a cohort of 265 LEVA users who are the real world LEVA users.
looked at all types of urinary incontinence in that group. And their symptoms from baseline out to eight weeks and also found that they demonstrated clinically meaningful change as measured with the UDI-6.
And so that's been published as well. Our support though for the care management team supports people up for a period of 12 weeks. So the structured cadence of support is for 12 weeks. We know that the literature broadly is in support of a program that's 12 months to three, I mean, 12 weeks to three months, variously described. And so we wanted to be consistent with that.
Kim (35:26.958)
Right. In the, just a quick question on the study, the people who, like the control group who was doing pelvic floor muscle training at home with, with their, they were provided written or visual feedback or instruction, I think is what you said. Were they instructed to do it in standing as well?
Jessica (35:46.349)
No, what we used there was we were looking for what is the right standard of care comparator because it's an active control. I mean, a lot of, you know, it's not an inactive control. So what we used was the standard handout from the American Urogynecological Association. They have a Voices for PFD patient education site that has...
you know, various instructions and different things, but it includes, you know, a handout on pelvic floor muscle exercises that begins in supine or a lying down position and then has some instructions for progression.
Kim (36:20.792)
Mm-hmm.
Kim (36:24.686)
Got it, very cool. And so the comparative, can you share the data, what the results were?
Jessica (36:31.581)
So I can share, I mean I certainly can, and I mean in the show notes I can give you just links to the publications if you want. I think for anyone who's really interested in diving deep, but I think for anyone who wants the Cliff Notes version, what we can tell you is that, you know, by eight weeks, you know, so that was our primary outcome. What we saw is that both groups improved, but that there was statistically superior and
Kim (36:36.515)
Sure.
Kim (36:42.845)
Mm-hmm.
Jessica (36:55.253)
clinically superior performance in the LEVA group as compared to the control group that was doing the at-home pelvic floor muscle exercises. That was demonstrated in both bladder diary outcomes, so three-day bladder diary outcome, and the UDI-6.
When we followed everyone out to 12 months, what we saw is that those results were durable so that there was still really clinically and statistically superior outcomes noted in the LEVA group in comparison to the Pelvic Foot Muscle Training group. One of the really neat ways that we can look, because sometimes when you do this research, like you're trying to figure out like how do we know that these numerical changes like have significance, you know, so there are different ways that can be looked at
is something called the patient acceptable symptoms state, abbreviated as PASS, that has been described that has been described for a lot of different health conditions. Essentially it looks at like what is the threshold on certain patient reported outcome measures below which people would feel like they are improved enough that they're no longer likely to seek care.
Right, because what we see with a lot of health conditions, among them, you know, incontinence, is that you can have improvement that is very meaningful for a patient. It's not like it's either cured or it's not, and that you exist in that dichotomy, but that it truly is, you know, improvement can be meaningful. So the PASS is something that we were able to kind of apply as another lens to look at the change, and that's been described for the UDI-6. And in our leave a user group,
that passed threshold and the Kegel Group did not. So it came below that at the eight week mark and that was sustained up to a year.
Kim (38:45.298)
And sustained also meaning sustained use. So the consistency of practice of that twice a day. Oh.
Jessica (38:51.017)
actually no. That's one of the most interesting things about it. I know, I know. We've always really thought that there needed to be ongoing and really indefinite use. And what we see is that regardless of continued use through several ways, we looked at the analysis that
there was durability of these results. We obviously didn't have a way to track that in the control group. It was self-reported during the initial eight weeks, and we asked them to attest to how much they did the exercises, but we're able to see, because as I mentioned, the data on adherence is passively captured by the device, and we found that most people did not continue to use Leva after the eight weeks. And yeah.
Kim (39:12.951)
Wow.
Kim (39:37.282)
Wow.
Jessica (39:38.973)
And when we looked, regardless of whether they used it or not, that the durability of those results was there. Yeah, it was an exciting finding. Yeah.
Kim (39:47.234)
Very cool, very cool. Can you share a little bit on the data of, what was the age, sort of the demographics of the group of women, what age ranges and life stages were they in?
Jessica (40:04.965)
Yeah, so we had just over 20% of the group was over 65 years old. And about 50% or more would be considered postmenopausal based on when we would expect menopause to hit. And a lot of the group, like the Mean BMI, really brought it to a group that would be classified as obese.
So there was like overweight or early stage low obesity in the group and about 20% were non-white. One thing that was really interesting is that this trial was conducted entirely in a decentralized way. So we partnered with academic centers. There were four urogynecology departments at major academic centers that were the investigators here and really led the study.
but the recruitment was done entirely through social media. It allowed us to recruit from about 25 states. So geographically, there was a really broad representation, much more so than we would have been able to have if only recruiting through in-person visits kind of in a brick and mortar type way.
Kim (41:01.293)
Wow.
Kim (41:05.591)
Wow.
Kim (41:19.222)
That's very, very cool. Very cool. Well, I am super excited about this device. I think it's been a long time coming. You know, we've seen some innovation, but this is all that you shared today, I think is really next level. And we'll, I mean, the fact that there's sustained, that part's really like mind boggling for me. That's amazing. Because I always say, you've got to be consistent. Right? Yeah.
Jessica (41:20.944)
Mm-hmm.
Jessica (41:45.977)
Right, right, right. Yeah, and I mean, I think that was a, it was a really exciting and, and yeah, a bit surprising about finding a place to see that didn't have a bearing, but that, you know, I think when we think about some principles of rehabilitation, it can start to make sense that if you, you essentially have something that needs to be rehabilitated, but the pelvic floor once upon a time for nearly everyone worked without us having to think about it.
Kim (41:54.157)
Yeah.
Kim (42:12.575)
Exactly. Yeah.
Jessica (42:13.321)
you know, and it got challenged enough in our daily tasks to kind of respond in a task dependent way. And it met the demands of all that we needed it to do until something happened and it didn't. And you know, and so.
Kim (42:24.694)
Right, right. And sometimes when something happens, that's what stalls us from the movement that's also building capacity and resilience. So when we can read, yeah, yeah. Okay, I love that.
Jessica (42:31.997)
Exactly. Yeah, yeah. So, I mean, there's a lot still for us to learn, but it seems that, you know, that this could actually be, you know, creating this meaningful dose of rehabilitation training, and that it, you know, is kind of a course of care. And, you know, hopefully it's that then the pelvic floor is doing more of what it should be doing without the focus training.
Kim (42:47.331)
Mm-hmm.
Kim (42:53.357)
Yeah.
Kim (42:59.406)
Exactly. Yeah, yeah. I love it. Where can people find more if they wanna learn more about the LEVA system and all the contributors, the people that are working there?
Jessica (43:01.739)
Yeah.
Jessica (43:11.526)
Yeah. So, so there is kind of a, you know, a growing presence on social media, but the best place that you could go to learn would be at levatherapy.com. So I'll provide that, you know, website for you. Yeah. In the show notes. That'd be the best place to find it.
Kim (43:26.102)
Yeah, the link will be in the show notes. Yep.
Kim (43:30.826)
Yeah, amazing. You are doing amazing work. Thank you so much for sharing. I am excited about everything that's gonna come ahead of us because of this and yeah, huge thanks to you.
Jessica (43:43.565)
Thank you, I appreciate it. It's been a fun and challenging several years, but I'm really, I'm proud of this product and believe it really fills a gap. There's so many people that never, ever talk to a clinician or any health professional or anyone about their incontinence, and most people just don't receive care, period.
Kim (43:51.328)
I'm out.
Jessica (44:13.514)
And I think it's been a real pleasure to be a part of building something that I think can start moving into filling that gap. Yeah, so thanks for the opportunity to share.
Kim (44:23.23)
Amazing. Thank you.
